One of the global leaders in Medical Technology providing solutions to a variety of therapeutic areas including oncology, infectious disease, biosurgery, drug delivery systems, and diabetes. This company has been highly-rated for their cohesive work environment that allows employees to grow internally within the company while striving to reach the company’s global goals.

Job Specifications:

This role will allow you to serve on New Product Development teams as a lead member, representing the Operations Lead. As the acting Operational lead you will serve as an operations liaison for manufacturing, process/equipment validation, and engineering, quality operations, materials management, supply chain and procurement. In this role, you are a crucial component in the successful launch of products at a global level.

Responsible for coordination and leadership of all operations related activities in the commercialization for CMC operations

Lead operation strategy

Serve as a cross-functional liaison in New Product Development and Operations to ensure processes and DFM inputs are used properly in New Product Development

Serve on product initiation teams

Work with budgetary partners

Provide smooth transfer of new products into production

Responsible for NPI processes

Implement and develop project metrics, dashboards, and other communication forums to provide cohesion internally and externally

Requirements:

Minimum BS in Engineering discipline.

Minimum 10 years of experience in a medical device or pharmaceutical industry and 7 years direct experience in leading new product introduction and commercialization activities desired.

Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, QSR, ISO, and Design Control and Regulatory procedures is required

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